In Focus
Building a national haemovigilance program
From vision to reality
Simon Benson Australian Red Cross Lifeblood, Australia
Establishing a national haemovigilance program is a significant undertaking. Although transforming the initial strategic vision into a practical, effective and sustainable system can be challenging, it is also highly rewarding.
Haemovigilance encompasses the systematic collection, analysis, and reporting of adverse events data associated with blood donation and transfusion. A disciplined approach, clear purpose and a structured design ensure a system that’s functionally aligned and fit for purpose. Success largely depends on the resources available, such as funding, staffing, and supporting infrastructure. Thoughtful planning, strong stakeholder engagement, and a commitment to continuous improvement are strong foundations in building a program that directly enhances transfusion safety and supports both patient and donor well-being.
For deeper insights beyond this review, extensive guidance is available from the World Health Organization (WHO), International Society of Blood Transfusion (ISBT), International Haemovigilance Network (IHN), and established programs such as the UK’s Serious Hazards of Transfusion (SHOT).
Where to start?
Key strategic questions which help define the structure include understanding the rationale for the program (WHY), the activities it will involve (WHAT), the timeline for key elements (WHEN), who will be responsible for managing it (WHO), the settings in which it will operate (WHERE), and how it will function operationally day-to-day (HOW).
Figure 1: Key strategic Questions
One of the most important early decisions is whether to build the program from the ground up, developing materials and systems from scratch or adapting elements from established programs. Customising existing resources can save considerable time and reduce the risk of missing essential elements. Stakeholder engagement and communication
Early involvement of the transfusion community and clear communication of the program’s purpose help encourage participation. In many countries, haemovigilance programs are voluntary, so willing participation is preferable to reluctant compliance. Stakeholder engagement, involvement of key people and regular communication with end users are essential to a program’s success. Health services are encouraged to identify a Transfusion Safety Officer or Transfusion Practitioner to act as a local haemovigilance champion and be the primary liaison between the program and clinical areas. Successful programs depend on collaboration and consistent dialogue between national coordinators, laboratories, clinicians, and health service leaders.
Components of the program
Haemovigilance activities can be distilled into three interconnected components: gathering and recording data, analysing data, and reporting findings. These steps define the program's operational structure, form a continuous quality improvement cycle, and, when performed effectively, drive meaningful change in transfusion practice.
Figure 2: Key components
The program’s scope should reflect the structure, culture, and regulatory environment of the national health system. Local systems at the hospital, state, or jurisdictional level will typically integrate with the national program.
Operational decisions must be made regarding whether to:
- focus on recipient and/or donor vigilance;
- capture only severe or sentinel events or all events, including near misses;
- monitor only labile blood components or extend to fractionated products, recombinant therapies, and potentially other substances of human origin (SoHO) such as donor breast milk or faecal microbiota;
- implement voluntary or mandatory reporting requirements.
Collecting and recording adverse event data
Effective data collection is at the heart of haemovigilance, but for users, it is important that reporting requirements are not onerous. Generally, the hospital’s laboratory will be responsible for collecting and collating reports and for managing the communication of adverse event reports to the program.
A logical starting point is to become familiar with established international haemovigilance definitions, such as those from the WHO1, 2, ISBT/IHN3, and the Council of Europe4. Adopting a common language supports consistent reporting and enables data comparison across various settings.
There are many methods for collecting and recording haemovigilance data. Simple programs may rely on paper forms or spreadsheets, with reports forwarded by users for central review.
More sophisticated programs might use electronic platforms. Web-based platforms that streamline submission can reduce transcription errors.
Regardless of the reporting method or tools, it is important that the data is complete, accurate, consistent, and sufficiently detailed to enable accurate event classification. A data dictionary or a similar resource that describes required data elements is a useful tool for standardising reporting.
What is the workload associated with a haemovigilance program?
Understanding workload expectations is important in planning. Large, well-established programs like SHOT process thousands of reports annually and require substantial staffing and expertise. Smaller programs, however, often handle a more manageable volume. For example, the day-to-day management and administration of a program receiving around 500 reports per year should be well within the capability of one person, with support from clinical specialists. Getting the full value from your haemovigilance program
Following data collection, reports undergo clinical review and final classification, usually by transfusion medicine specialists and are analysed to identify patterns and trends. Denominator data (e.g. the number of units transfused) is used to calculate event rates. Variability in data collection practices across hospitals or different jurisdictions can affect the reliability of comparisons, highlighting the need for standardisation.
The value of haemovigilance is the insights it generates. By monitoring adverse events and near misses, programs can detect emerging risks, identify system weaknesses, and recommend targeted interventions. Evaluating the impact of change initiatives drives continuous practice improvement (CPI).
Haemovigilance needs to be a two-way process. Producing regular or annual program reports reinforces engagement, highlights important patterns or issues, and demonstrates the program’s relevance and impact.
Conclusion
Establishing a national haemovigilance program brings together many elements of the transfusion process. Collaboration is essential, not only within national systems but also with international networks and experts who can offer practical support and share proven approaches. A wealth of resources, tools, and global experience is available to assist those undertaking the journey and help avoid common pitfalls.
Ultimately, haemovigilance serves a singular purpose: improving donor and patient safety. By identifying trends, determining root causes, informing policy, supporting research, and enabling early warning of emerging risks, haemovigilance systems play a critical role in safeguarding transfusion practice. Success relies on simplicity, clarity, and consistent engagement across the transfusion community, and haemovigilance ensures safety improvements are both meaningful and sustained.
References
- User guide for navigating resources on stepwise implementation of haemovigilance systems. Geneva: World Health Organization; 2022.
- A guide to establishing a national haemovigilance system. Geneva: World Health Organization; 2016.
- International Haemovigilance Network/International Society for Blood Transfusion. Proposed standard definitions for surveillance of non-infectious adverse transfusion reactions. ISBT; 2011.
- Guide to the preparation, use and quality assurance of blood components. Strasbourg: European Directorate for the Quality of Medicines & HealthCare (EDQM)Council of Europe; 2025.
